Method and apparatus for intravascular two-dimensional ultrasonography

ABSTRACT

A catheter is provided for insertion in the blood vessel of a patient for ultrasonically imaging the vessel wall. The catheter includes a tubular element and an internally housed drive cable for effective circumferential scan about the catheter of an ultrasonic generating means. Both the tubular element and the drive cable are of a size and flexibility sufficient to permit their introduction into the vessel and subsequent advancement through the vessel to the location of the vessel wall where imaging is desired.

This is a continuation of U.S. application Ser. No. 08/467,178, filed onJun. 6, 1995 and now U.S. Pat. No. 5,865,178, which is a continuation ofU.S. application Ser. No. 08/162,412, filed on Dec. 3, 1993, now U.S.Pat. No. 5,676,151, which is a divisional of U.S. application Ser. No.08/014,906, filed on Feb. 1, 1993, now U.S. Pat. No. 5,313,949, which isa continuation of U.S. application Ser. No. 07/826,260, filed on Jan.24, 1992, now abandoned, which is a continuation of U.S. applicationSer. No. 07/649,048, filed on Feb. 1, 1991, now abandoned, which is acontinuation of U.S. application Ser. No. 07/290,533, filed on Dec. 23,1988, now U.S. Pat. No. 5,000,185, which is a continuation-in-part ofU.S. application Ser. No. 06/834,893, filed on Feb. 28, 1986, now U.S.Pat. No. 4,794,931. The entire disclosures of all of the aforementionedapplications are incorporated herein by reference. The presentapplication is related to application Ser. No. 07/290,217, filed on Dec.23, 1988 (U.S. Pat. No. 5,049,130), commonly assigned herewith, thedisclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

This invention relates to a catheter apparatus, system, and method forintravascular two-dimensional ultrasonographic imaging, and moreparticularly to such an apparatus, system, and method for guiding andmonitoring interventional therapy to reduce vascular stenosis.

Ultrasonic two-dimensional imaging apparatus and systems have heretoforebeen provided for use in endoscopy for examining the gastrointestinaltract. Such a device is disclosed in U.S. Pat. No. 4,494,549. Suchdevices, however, have been relatively large and inflexible and arecompletely unsuitable for use within the vascular system of the humanbody. In addition, there is no provision for guiding such devices intospecific branches of blood vessels.

There is, therefore, a need for a new and improved catheter apparatus,systems, and methods which can be utilized for performing intravasculartwo-dimensional ultrasonographic imaging. It would be particularlydesirable if such imaging apparatus and methods could be combined with avariety of intravascular therapeutic modalities, such as angioplastyatherectomy, laser ablation, and the like, in order to providesimultaneous imaging and recanalization procedures.

SUMMARY OF THE INVENTION

According to the present invention, a method for imaging the interior ofa blood vessel comprises scanning an ultrasonic signal in a preselectedpattern about said interior. By receiving ultrasonic energy reflectedfrom the interior surface of the vessel, including any stenosis orocclusion present, an image or profile of the blood vessel may beproduced. Conveniently, the ultrasonic signal is generated by atransducer located at the distal end of a vascular catheter comprising aflexible tubular member. The transducer may be manipulated directly tosweep the ultrasonic signal in a desired pattern, including radial,planar, and conical. Alternatively, the transducer may be fixed withinthe catheter and a reflective surface manipulated to sweep theultrasonic signal in a desired pattern. The imaging method of thepresent invention is advantageously combined with interventionaltherapeutic techniques to reduce vascular stenosis, where the stenosismay be imagined prior to, during, and after intervention to help directthe interventional activity to where it will be most effective.

In general, it is an object of the present invention to provide acatheter apparatus, system, and method for intravascular two-dimensionalultrasonography.

Another object of the invention is to provide an apparatus, system, andmethod of the above character which has a high resolution capability.

Another object of the invention is to provide an apparatus, system, andmethod of the above character which can be utilized for assessingendovascular lesions.

Another object of the invention is to provide an apparatus, system, andmethod of the above character which can be utilized for monitoring theresults of interventional therapy.

Another object of the invention is to provide an apparatus, system, andmethod of the above character which can be used with angioplasty,atherectomy, laser ablation, drug deliver, and similar vascularinterventional methods and devices.

Another object is to provide an apparatus, system, and method capable ofselective cannulation of branch vessels.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments are set forthin detail in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view partially in cross-section of acatheter apparatus incorporating the present invention.

FIG. 2 is an enlarged cross-sectional view of the distal extremity ofthe apparatus shown in FIG. 1.

FIG. 2A is a detail view illustrating an alternate mounting of a crystaltransducer to provide a conical sweep pattern.

FIG. 2B is an alternate embodiment of the distal extremity of theapparatus shown in FIG. 1, modified to be inserted over a movableguidewire and with the cutting direction reversed.

FIG. 3 is an enlarged cross-sectional view of an intermediate portion ofthe apparatus shown in FIG. 1.

FIG. 4 is an enlarged cross-sectional view taken along the line of 4—4of FIG. 1.

FIG. 5 is an isometric view of the crystal assembly which forms a partof the apparatus shown in FIG. 1.

FIG. 6 is a schematic block diagram of the electrical and electronicapparatus utilized in the system.

FIG. 7 is a two-dimensional display of an ultrasonogram which can beobtained with the apparatus and system shown in FIGS. 1-6.

FIG. 8 is an enlarged cross-sectional view of another embodiment of acatheter apparatus incorporating the present invention.

FIG. 9 is a cross-sectional view taken along the lines of 9—9 of FIG. 8.

FIG. 10 is an enlarged cross-sectional view of still another embodimentof a catheter apparatus incorporating the present invention.

FIG. 10A is a detail view illustrating an alternate configuration of areflective surface to provide a conical sweep pattern.

FIG. 10B is an alternate embodiment of the distal extremity of thecatheter apparatus of FIG. 10, modified to provide a fixed ultrasonictransducer located proximally of a reflective surface on a cutter.

FIG. 11 is an enlarged cross-sectional view of another embodiment of thecatheter apparatus incorporating the present invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

In general, the catheter apparatus of the present invention includes aflexible tubular element which is adapted to be inserted into a bloodvessel in the vascular system and a flexible rotatable elongate elementwhich is disposed in the tubular element. In a first embodiment, anultrasonic transducer is carried at the distal end of the flexiblerotatable elongate element, and electrical circuitry carried at thedistal end of the flexible tubular element is connected to theultrasonic transducer for supplying signals to and receiving signalsfrom the transducer. In a second embodiment, a reflective surface iscarried by the distal end of the flexible rotatable elongate element,and the ultrasonic transducer is mounted in the distal tip of theflexible tubular element so that signals generated by the transducerwill be reflected by the reflective surface. In both embodiments, atransmitter is provided for supplying signals to the ultrasonictransducer and a receiver is provided for receiving signals from theultrasonic transducer. A motor drive is usually provided for rotatingthe flexible elongate element along manual rotation may also beemployed. By rotating the flexible elongate element, the transducersignal can be swept in a desired pattern, either directly by thetransducer in the first embodiment, or indirectly by the reflectivesurface in the second embodiment. Timing and control circuitry isprovided for controlling the operation of the transmitter and receiverand optionally the motor drive. A display is provided which is operatedunder the control of the timing and control circuitry for displayingimage information that is received by the receiver.

The catheters of the present invention may further includeinterventional capability for recanalization of occluded regions withinthe imaged blood vessel. Recanalization is intended to refer to both theopening of total occlusions, as well as broadening of the vessel lumenin partial occlusions. Catheters combining ultrasonic imaging capabilitywith atherectomy devices for severing of stenotic material are describedin detail hereinafter. The methods of the present invention, however,are not limited to atherectomy and include a wide variety of otherinterventional techniques that may be performed with vascular catheters.Suitable interventional techniques include balloon angioplasty, laserablation angioplasty, balloon embolectomy, aspiration embolectomy, heatprobe ablation, abrasion, drilling, therapeutic ultrasound, and thelike. Also, the catheters may be adapted for introducing clot-dissolvingdrugs, such as tissue plasminogen activator, streptokinase, urokinase,and the like, in order to reduce the stenosis, as well as plateletreceptor blockers and drugs which limit cell multiplication in order toinhibit restenosis. Conveniently, perfusion lumens and ports may beprovided in the catheter to provide for the administration of suchdrugs.

A first exemplary construction of a catheter apparatus 11 constructed inaccordance with the principles of the present invention comprises anelongate tubular assembly 12 includes an elongate flexible tubularelement 13 which is provided with four lumens 14, 16, 17, and 18 withthe lumen 14 serving as a torque tube, lumen 16 serving as a balloontube, and lumens 17 and 18 serving as infusion tubes or lumens ashereinafter described. The tubular element 13 may conveniently be formedas a single extrusion which provides the four lumens, with the lumens 14and 16 being substantially circular in cross-section, and the lumens 17and 18 being arcuate in shape with the configuration of each beingdetermined by three arcs with one of the arcs being concentric with theouter diameter of the tubular element 13 and with the two smaller arcsbeing concentric with lumens 14 and 16, respectively.

A braided shield 21 is provided on the exterior of the tubular element13 and takes the form of one or more layers of braided strands 22 formedof suitable magnetic material, such as an electrical shield. A covertube 23 covers the braided shield 21 and extends the length of thetubular element 13. The cover tube 23 can be formed of a suitablematerial such as a heat shrinkable plastic which is shrunk tightly ontothe braided shield 21 and provides a smooth outer surface so the tubularassembly 12 can readily enter a vessel of the vascular system of apatient.

A work performing device such as an atherectomy or cutting device of thetype described in European patent application 163 502 may be provided inthe distal extremity of the tubular assembly 12. A suitable cuttingdevice is described in said European application and consists of ahousing 27 that is provided with a cutout 28. A rotary cutter 29 isrotatably disposed within the housing 27 and is provided with a hub 31that is secured to a flexible rotatable torque cable 32. The cable 32 isdisposed in and extends through the torque tube lumen 14. The torquecable 32 is formed of a suitable material such as stainless steel. Thehousing 27 is provided with a rounded tip 33 having a recess 34 which isadapted to receive material which is removed by the rotary cutter 29 asthe cutter 29 is advanced as hereinafter described. A spring tip guideor guidewire 36 capable of being shaped is secured to the rounded tip 33and extends forwardly therefrom and serves to guide or steer the housing27 as the tubular assembly 12 with the cutting device 26 secured theretois introduced into the vessel of the vascular system of the patient. Asshown, the spring tip guide 36 can be secured to the rounded tip 33 bysuitable means, such as solder 37. It thus can be seen that theguidewire 36 is associated with the housing 27. Alternatively, a movableguidewire 38 (FIG. 2B) can be utilized to facilitate steering of thecatheter 11 into the desired vessel of the patient.

A balloon 41 of an expandable type is optionally secured to the housingin a region opposite the cutout 28 and has its distal extremity bondedaround the tip 33 by suitable means, such as an adhesive 42. As shown inFIG. 2, the balloon 41 underlies substantially the entire length of thehousing 27. The balloon 41 is in communication with a balloon tube 43that extends through the balloon tube lumen 16 in the tubular element13. The balloon tube 43 is provided with a lumen 44 through which amedium can be introduced for inflating the balloon 41 and removed fordeflating the balloon 41. The proximal extremity of the balloon 41 andthe proximal extremity of the housing 27 are secured to the distalextremity of the tubular assembly 12 by suitable means, such as heatshrinkable tubing 46.

A system 49 is provided at the distal end 49 of catheter 11 for imagingthe region in which the work performing device is located, said systemusually being a two-dimensional ultrasound image system. The system 49includes an ultrasonic transducer, such as a single crystal 51 (see FIG.5), which is mounted on the hub 31 and is secured thereto by suitablemeans such as an adhesive. The crystal 51 is part of an assembly 52. Thecrystal 51 should be capable of operating at a frequency range of 5 to50 megahertz and typically can be formed of a suitable material such asbarium titanate or cinnabar. As can be seen from FIG. 5, the crystal 51has a rectangular block-like configuration and has two opposed surfacescovered by metallic conducting films 53 and 54 formed of a suitablematerial such as chrome or gold. The material of the films can be formedof a foil or can be in the form of films evaporated or sputtered ontothe opposite surfaces of the crystal 51. The films 53 and 54 serve aselectrodes and are connected to connecting wires 56 and 57 by suitablemeans, such as solder. Means is provided for damping out theoscillations from the backside of the crystal 51 and takes the form of arectangular block 58 formed of a suitable backing material. The backingmaterial can be formed in a conventional manner so as to cancel outoscillations from the side of a crystal in which the backing material isdisposed.

The present invention, however, is not limited to the use ofpiezoelectric crystal oscillators as the ultrasonic transducer, andorganic electrets such as polyvinylidene difluoride (PVDF) andvinylidene fluoride-trifluoroethylene copolymers may also find use. PVDFis particularly suitable as a transducer at higher frequencies,typically at or above 40 MHz.

The wires 56 and 57 are braided onto the torque cable 32 and rotate withthe torque cable The wires 56 and 57 extend towards the proximalextremity of the tubular assembly 12 and extend into a fitting 61 (seeFIG. 3) formed of a suitable material such as plastic. A pair ofspaced-apart slip rings 62 and 63 formed of a conducting material suchas copper are secured to the torque cable 32. The wire 56 is bonded tothe slip ring 62, and the wire 57 is bonded to the slip ring 63. Afitting 66 is provided which has a threaded bore 67. The tubularassembly 12 extends through the fitting 66 and a reinforcing sleeve 68extends over the portion of the tubular assembly 12 extendingtherethrough. A pair of spring urged contacts 71 and 72 are carried bythe fitting 66 and are adapted to slidably engage the slip rings 62 and63. The contacts 71 and 72 are connected to conductors 73 and 74. Agrounding lug 76 is provided on the fitting 66 and makes electricalcontact with the braided shield 21. A conductor 77 is connected to thegrounding lug 76.

A male fitting 78 (see FIG. 1) is threaded into the threaded bore 67. Asingle arm adapter 81 is mounted in the male fitting 78 and carries anarm 82 having thereon a balloon inflation port 83 that is incommunication with the lumen 44 in the balloon tube 43 disposed in thetubular assembly 12. The single arm adapter 81 is secured to a rotatingadapter 86 of a conventional type and through which the tubular assembly12 extends. Another single arm adapter 87 is mounted in the rotatingadapter and is provided with a side arm 88 having an infusion port 89disposed therein which is in communication with the infusion lumens 17and 18 provided in the tubular assembly 12. A tapered fitting 91 ismounted in the single arm adapter 87 and is provided with a threadedbore 92 which carries an O-ring 93 that is adapted to be engaged by amale type fitting 94 to form a liquid-tight seal between the tubularassembly 12 and the torque cable 32 which extends therethrough. Thetorque cable 32 is secured to a suitable drive member such as a clutchmember 98 of the type described in European application 163 502 and U.S.Pat. No. 4,771,774, the disclosures of which are incorporated herein byreference. The clutch member 98 is adapted to be secured to a motordrive means of the type described in U.S. Pat. No. 4,771,774 consistingof a motor drive unit which in the present application is identified asa motor 99 (see FIG. 6). The motor 99 is driven by and is under thecontrol of electronic circuitry forming a part of system 49. The part ofthe system 49 shown in block diagram form is substantially conventionaland can be of a suitable type such as certain equipment identified asModel 851B manufactured by Advanced Technology Laboratories, Inc., ofBothel, Wash. As shown in FIG. 6, such apparatus includes a timing andcontrol block 102 that supplies pulses to a transmitter 103. The outputof the transmitter 103 is supplied through a transmit receive switch 104which supplies the signals on the conductors 73 and 74 through the sliprings 62 and 63 onto the conductors 56 and 57 connected to the crystal51. During the time that the transmitter 103 is supplying high frequencyenergy to the crystal 51, the crystal 51 is being rotated by the motordriving the torque cable 32 with the motor 99 being under the control ofthe timing and control block 102. The motor 99 is of a type such as anopen loop stepping motor or a closed loop servo controlled motor whichcan be driven by the timing and control block 102.

As an alternative to the use of an external motor 99 connected to thecutter 29 by torque cable 32, it would be possible to constructcatheters according to the present invention utilizing micromotorswithin the distal extremity of the catheter. The micromotors could beattached to directly rotate the cutter and transducer (or reflectivesurface as described hereinafter) typically by mounting at the end of anonrotating cable analogous to torque cable 32.

The transmitter generates a voltage pulse, typically in the 10 to 50volt range, for excitation of the transducer crystal 51. Supplying suchvoltage pulses to the crystal causes the transducer to produce sonicwaves which emanate therefrom into the surrounding tissue structure.Portions of the sonic energy wave are reflected by the tissue structureback to the transducer and the transducer 51 acts as a receiver andpicks up the sonic vibrations and converts them into electrical signalswhich are supplied by the conducting wires 56 and 57 back to the sliprings 62 and 63 through the conductors 73 and 74 and through thetransmit receive switch 104 to a receiver 106. These signals areamplified and supplied to a display unit 107 which includes a CRT screen108 under the control of the timing and control block 102 to supply animage 109 on the display 108 which can be of the type shown in FIG. 7.As can be seen from FIG. 7, as viewed through 360°, the vessel wall 111of the image 109 is shown as indicated, having different cross sectionsdepending upon the buildup of plaque therein. A central region 112 ofthe image is eclipsed because of the imaging catheter. Alternatively, ifdesired, only a sector of a lesser angle than 360° can be viewed.

The catheter apparatus of the present invention can be constructed invarious sizes. For example, in a 9 French size, the balloon can have alength of approximately 3 centimeters. Sizes down to 3 French and belowcan be accomplished with the construction of the present invention Theseparticular dimensions are exemplary only and not intended to limit thescope of the present invention in any way.

Operation and use of the catheter apparatus, system and method duringintravascular ultrasonography can now be briefly described as follows.Let it be assumed that it is desired to utilize the apparatus, systemand method of the present invention to remove the atheroma in a bloodvessel of a patient. The catheter of the catheter apparatus of thepresent invention is introduced into a vessel of the patient as, forexample, into the femoral artery and introducing the catheter into theartery by the use of the guidewire 36. The progress of the catheter intothe vessel of the patient can be observed under x-ray fluoroscopy. Assoon as the cutting device has entered into a region which is desired toremove certain material from the vessel and before a cutting operationis commenced, the atheroma itself can be viewed by operation of theultrasonic imaging system 49. This can be accomplished by operating thetiming control block 102 to cause operation of the motor 99 which inturn causes rotation of the torque cable 32 and the crystal assembly 52to scan the interior of the vessel in which the crystal 51 is disposed,usually at a rotation rate in the range from about 100 to 20,000 rpm,more usually from about 500 to 2,000 rpm. An image of what is beingscanned will appear on the screen 108 of the display device 107Alternatively, the torque cable 32 may be manually rotated (or aimedwithout rotation) to provide a desired image. Generally, however,motorized rotation will provide a higher definition image. During thetime this rotary scanning is taking place, the cable 32 can be advancedto advance the cutter so that the entire region in which the material isto be removed can be scanned. Usually, the cable 32 is advancedincrementally so that distinct cross-sectional images will besuccessively produced, allowing the operator to determine the length andtopography of the region. Alternatively, the entire catheter apparatus11 may be axially advanced or retracted within the blood vessel lumen toprovide a plurality of cross-sectional images to allow assessment of theentire length of the atheroma.

After the scan, the cable 32 can be retracted slightly (or the catheter11 repositioned) so that the proximal extremity of the cutout 28 lies atthe proximal extremity of the atheroma. In order to stabilize thecutting device, the balloon 41 can be inflated so as to urge the cutout28 of the housing 27 towards the portion of the atheroma it is desiredto remove. The motor 99 can then be energized to rotate the cutter 29.As the cutter 29 is rotated, it can be advanced to progressively removethe material which is disposed within the cutout 28 of the housing 27.As this material is removed it is pushed forwardly and eventually movesinto the recess 34. The balloon 41 can then be deflated and the catheterapparatus removed from the vessel after which the material which hasbeen deposited in the recess 34 can be removed and the cutting devicecleaned for reinsertion into the vessel of the patient for removal ofadditional material from the vessel if required.

During the time that the cutting operation is taking place, the cuttingoperation can be viewed ultrasonically by the rotating crystal 51 thatplaces an image on the screen 108. From this image it can be ascertainedhow well the cutter is performing in removing the material and whetheror not an additional pass of the cutter is required. It should beappreciated that, if necessary, several passes of the cutter can be madeand, if necessary, the catheter assembly can be removed from the vesselof the patient to clean out material which has been removed anddeposited in a recess 34.

As illustrated in FIG. 2, the ultrasonic transducer 51 is oriented todirect the ultrasonic signal in a direction substantially radiallyoutward relative to the axis of the flexible tubular element 13. It willsometimes be desirable, however, to incline the ultrasonic transducerrelative to the tubular axis, as illustrated at 51′ in FIG. 2A. Byinclining the transducer 51′, the ultrasonic signal is directed at aforward angle α relative to the tubular axis. By rotating the inclinedtransducer 51′, the ultrasonic signal will sweep a conical patterndirected forward of said transducer. The angle α may be in the rangefrom about 10° to 85°, usually being in the range from 20° to 60°.Scanning with a conical sweep is desirable because it can provideforward viewing at or in front of the location where the cut is beingmade.

An alternate embodiment 11′ of catheter 11 is illustrated in FIG. 2B.The catheter 11′ is similar to that of catheter 11, except that it ismodified to permit insertion of the catheter 11′ over a movableguidewire 38 and the cutter 29′ is reversed to provide cutting when thecutter is translated in the proximal (rearward) direction. Themodifications include providing a penetration 39 in the distal tip ofhousing 27 and an axially aligned penetration 40 in the cutter 29′. Theultrasonic transducer 52′ is mounted on the distal end of cutter 29′,and torque cable 32′ include an axial lumen. In this way, the catheter11′ is inserted by conventional techniques over guidewire 38, with theguidewire passing through penetrations 39 and 40 and the lumen of torquecable 32.

Another embodiment of the catheter apparatus of the present invention isshown in FIGS. 8 and 9. Many of the parts are very similar to the partsutilized in the embodiment of the invention shown in FIG. 1 and havebeen given the corresponding numerals. The ultrasonic transducer 52 ismounted in a cavity 53 formed to the rear of the rotary cutter 29. Thedistal extremity of the catheter apparatus shown in FIG. 8, (i.e., tothe left) differs from the apparatus shown in FIG. 1 in that theconducting wires or leads connected to the ultrasonic crystal 52 areconnected to the outside world at a point which is proximal of anadapter 122 whereas in the embodiment shown in FIG. 1, the connectorsare connected at a point which is distal of the adapters 82 and 88.Thus, there is shown an adapter 122 which is provided with an arm 123through which dye injection and pressure measurements can be made andanother fitting 124 which can be utilized in inflating and deflating theballoon 41. Another adapter 126 is provided which is threaded into theproximal end of the adapter 122 and forms a sealing engagement with anO-ring 127 carried by the adapter 122. The torque cable 32 extendsthrough the adapter 126 and is connected to a clutch member 128. Theclutch member 128 which carries a finger operated member 129 is adaptedto be secured to motorized drive means of the type hereinbeforedescribed for causing rotation of the torque cable 32.

As hereinbefore explained, the conducting wires connected to theultrasonic transducer 5. are braided into the guidewire 32. Means iscarried by the adapter 126 which is adapted to make contact with theconducting wires connected to the crystal 52 and consists of brushes 131and 132 which are yieldably urged by springs 133 towards the torquecable 32 so as to make contact with the conducting wires or leadscarried by guidewire 32. The springs 133 are held in place by pins 134which are frictionally seated within the adapter 126. Conducting wires136 and 137 are connected to the pins 134. These wires 136 and 137 areconnected into the system in a manner hereinbefore described with theprevious embodiments. The operation of this embodiment is very similarto that described in conjunction with the operation of the embodimentshown in FIG. 1.

Operation of this embodiment of the invention is very similar to thathereinbefore described with the principal advantage being that leadswhich are connected to the crystal and for receiving signals from thecrystal are disposed proximally of the two arm adapter 122.

As a modification of catheter 121, cutter 29 could be provided with anabrasive external surface, either in place of or in addition to theforward cutting edge. Such an abrasive surface would be useful to removeatheroma and plaque by contact abrasion.

Still another embodiment 151 of the catheter apparatus of the presentinvention is shown in FIG. 10. Certain parts of this catheter apparatus151 are very similar to those hereinbefore described and are identifiedby the same numbers. Thus there has been provided a housing 27 which hasan outwardly facing cutout 28. A coil spring guidewire 36 is secured tothe distal extremity of the housing 27 as shown (although the catheter151 could easily be adapted to receive a movable guidewire as describedabove in connection with the embodiment of FIGS. 1-4 The balloon 41 iscarried by the housing and has its distal extremity secured to thehousing by a band 92. The balloon 41 is disposed outside of the housing27 on the side opposite the cutout 28. A flexible tubular assembly 154is secured to the proximal end of the housing 27. A three-arm adapter152 is mounted on the proximal extremity of the tubular assembly 154.The tubular assembly 154 comprises a flexible tubular element formed ofa suitable material, such as plastic which is provided with a ballooninflation lumen 155 that is in communication with the interior of theballoon 41 and extends into a balloon inflation port 156 provided as apart of the three-arm adapter 152.

A crystal 157 is carried by the housing 27 in a stationary position. Asshown, the crystal 157 is mounted vertically or in a direction that isat right angles to the longitudinal axis of the housing 27. It can bemounted in the distal extremity of the housing 27 in a suitable mannersuch as by an adhesive. A suitable sound absorbing material 158 isprovided behind the ultrasonic crystal 157 and fills the space betweenthe crystal 157 and the distal extremity of the housing 27. A pair ofconducting wires 161 are connected to the ultrasonic crystal 157 andextend rearwardly through the housing 27 and are connected into sockets162 provided in a side arm 163 forming a part of the adapter 152.

The flexible tubular element 154 is provided with a large lumen 164extending the length thereof and which has a rotatable flexible drivecable 166 disposed therein. The flexible torque cable 166 is formed inthe manner hereinbefore described and is secured to a generallycylindrical member 167 which as hereinafter described, serves as areflector mount and also serves to carry a rear-facing rotary cutter169. Thus, as shown, the member 167 is provided with reflective surface168 which is inclined at an angle of approximately 45° and faces thetransducer 157 in such a manner so that sound waves propagated by thetransducer impinge upon the surface 168 and are propagated outwardly ina direction substantially transverse, i.e., at right angles, to thelongitudinal axis of the housing 27. A circular cutting edge 169 isprovided on the member 167 at the proximal extremity thereof. Atruncated conical recess 171 is provided in the proximal extremity ofthe member 167. The conical recess 171 can be used as a reservoir forcollecting material as it is severed by the circular cutting edge 169.

The angle of inclination of the reflective surface 168 relative to theaxis of housing 27 may be varied, particularly being increased, asillustrated in FIG. 10A, where angle β may be in the range from 10° to85°, usually being in the range from 10° to 40°. By inclining thereflective surface by an angle β less than 45°, the reflected ultrasonicsignal will sweep in a rearward conical pattern which allows viewing ator in front of, (i.e., to the right in FIG. 10), the cutting edge 169 ofmember 167.

The three-arm adapter 152 is provided with another arm 173 which servesas an infusion port and which is in communication with the lumen 164through which the drive cable 166 extends. This lumen 164 opens into theinterior of the housing 27 and is in communication with the cutout 28.Another adapter 176 is threaded into the proximal extremity of theadapter 162 and engages an O-ring 177. The drive cable 166 extendsthrough the adapter 176 and has its distal extremity secured to theclutch member 128. As hereinbefore explained, the clutch member 128 canbe secured to a motorized drive means (or may be manually rotated) forcausing rotational movement of the cutter and mirror member 167.

An alternate embodiment 151′ of catheter 151 is illustrated in FIG. 10B.The catheter employs a fixed ultrasonic transducer 157′, but cutter 169′is reversed to provide for forward cutting. Forward cutting is oftenadvantageous in that severed stenotic material is less likely to becomeentangled with the torque cable 166′. Ultrasonic transducer 157′ will beprovided with a central penetration to allow passage of the torque cable166′, and said transducer will be located at the proximal end of housing27′, but otherwise the construction of catheter 151′ will be the same ascatheter 151.

In a further modification, it is possible to secure the ultrasonictransducer 157′ onto the torque cable 166′. Wires connecting thetransducer 157′ to the external receiver and transmitter would then beattached to the torque cable 166′ and coupled to the outside in a mannersimilar to that illustrated in FIGS. 1-4. The transducer 157′ would thentranslate axially in tandem with the cutter 169′ and the mirror 168′. Bymaintaining a fixed distance between the cutter 169′ and transducer157′, signal processing to produce an image is simplified.

Operation of the catheter apparatus 151 shown in FIG. 10 may now bedescribed as follows. The operation of this device in many respects isvery similar to that hereinbefore described with respect to theplacement of the catheter in the vessel. The housing 27 can bepositioned in the stenosis hereinbefore described and ultrasonic imagingcan be carried out by supplying pulses of electrical energy to theultrasonic transducer 157 which emanates ultrasonic energy and directsthe same onto the reflector 168 which reflects the ultrasonic energy upinto the tissue surrounding the housing. Rotation of the mirror 168causes an image to be formed that can be viewed in the mannerhereinbefore described. This imaging can be carried out by rotating thecable 166 and at the same time advancing the drive cable 166 throughoutthe length of the cutout 28 to view the stenosis. After the viewingoperation has been accomplished and it is ascertained that it isdesirable to remove the material creating the stenosis by use of thework performing device in the form of the cutter member 167, the cuttermember 167 can be advanced to the distal extremity of the cutout 28.With the cutout 28 in the proper location, the balloon 41 can then beinflated through the balloon inflation port 156 to urge the housing 27in a direction so that the stenosis enters the cutout. As soon as thishas been accomplished, the cutter member 157 can be rotated at a highrate of speed and gradually retracted, (i.e., translated to the right inFIG. 10), to cause the material forming the stenosis to be severed bythe blade 169 on cutter member 167 and collected within the recess 171.This cutting and collecting operation can be continued until the cuttermember 167 has been advanced to the extreme proximal position. At thistime, the catheter apparatus 151 can be removed and the tissue collectedwithin the recess 171 can be removed. Thereafter, additional insertionsof the catheter apparatus can be made and the same cutting operationsperformed until desired amount of material has been removed from thearea of the stenosis to provide for increased blood flow through thevessel.

Another embodiment of a catheter apparatus 180 incorporating the presentinvention is shown in FIG. 11. The catheter apparatus 180 is utilizedsolely for imaging purposes and employs a fixed ultrasonic transducer182 which transmits its signal against a rotating reflective surface204. The catheter apparatus 180 is constructed very similar to thecatheter apparatus 151 shown in FIG. 10 with the exception that thecutting mechanism has been eliminated. The use of such a catheterapparatus 180 is desirable where it is unnecessary to provide a cuttingfunction (or other interventional treatment modality). The catheterapparatus 180 also has many parts that are similar to the catheterapparatuses heretofore described. Thus there is provided a housing 27which carries on its distal extremity a coil spring guide 36. As before,however, the catheter 180 can also be adapted to be inserted over amovable guidewire within the scope of the present invention. Theultrasonic transducer 182 is provided in the distal extremity of thehousing 27 and is disposed vertically or in a direction that isperpendicular to the longitudinal axis of the housing A sound absorbingbacking material 183 is provided in the distal extremity of the housingbehind the transducer 182. Conducting wires or leads 184 are connectedto the transducer 182. The proximal extremity of the housing 27 isconnected to the distal extremity of flexible elongate tubular element186 that is connected to a two-arm adapter 187. The leads 184 extendthrough the tubular element 186 and are connected to sockets 188provided in the arm 189 of the two-arm adapter 187. The tubular element186 is provided with a large lumen 191 that carries the drive cable 192.The drive cable 192 is connected to a clutch member 193 of the typehereinbefore described which is adapted to be driven by motive means inthe manner hereinbefore described. The clutch member 193 is providedwith a flange 194 that cooperates with a flange 196 on the adapter 187.The adapter 187 carries an O-ring 197 seated against another flange 198forming a part of the adapter 187. The O-ring 197 forms a liquid-tightseal with respect to the drive cable 192. The clutch member 193 is thusheld in a fixed longitudinal position while still permitting rotation ofthe same. The adapter 187 is provided with a tapered surface 199 adaptedto fit into a motor drive means. Alternatively, the clutch member 193can be adapted for manual rotation. Alternatively, the clutch member 193can be adapted for manual rotation.

The drive cable 192 has its distal extremity secured to a rotatingmember 203 which is provided with an inclined reflective surface 204which serves as a reflector for reflecting ultrasonic energy generatedby the transducer 182 in a transverse direction relative to thelongitudinal axis of the housing 27. The angle of inclination of surface204 may vary, typically between 45° and 85° provide for forward viewingas described above, depending on the sweep geometry desired. Asillustrated, the torque cable 192 is unable to axially translate withinthe lumen 191. Thus, the reflective surface 204 on rotating member 203remains in a fixed longitudinal position relative to the housing 27 andcannot be advanced or retracted with respect to the ultrasonictransducer 182. The reflective surface 204 can, of course, be axiallytranslated within a blood vessel by movement of the catheter 180 as awhole. Also, the catheter 180 could be modified to permit axialtranslation of the rotating member 203 within the housing 27 (in amanner similar to the previous catheter embodiments), but generally thiswill be unnecessary.

The large lumen 191 in flexible elongate tubular element 186 is incommunication with a side arm port 206 that forms a part of the two-armadapter 187. The housing 27 should be formed of a material that causesminimal attenuation of the ultrasonic signal which is transmitted andreceived by transducer 182. Suitable materials include polyethylene,silicone rubber, polyvinyl chloride, polyurethanes, polyesters, naturalrubbers, and the like. Alternatively, the housing may be formed ofacoustically opaque materials if a cutout 207 (shown by the dashedlines) is provided through which the ultrasonic energy can pass.

The operation of the catheter apparatus 180 shown in FIG. 11 is verysimilar to that hereinbefore described with the exception that thecutting operation is omitted. With this catheter apparatus, the devicecan be inserted in the same manner as with respect to the other deviceshereinbefore described. When the device is in the desired location, asfor example, in the stenosis, the stenosis can be imaged ultrasonicallyby causing the rotating member 203 to be rotated with respect to thecrystal 182 to cause ultrasonic energy to be directed upwardly andoutwardly through the housing 181 to impinge upon the sidewalls of thevessel in which the catheter apparatus 180 is positioned. If a differentlongitudinal position is desired to be scanned, the entire catheterapparatus 181 can be shifted longitudinally in the vessel to the desiredlocation. After the ultrasonic imaging has been completed, the catheterapparatus 180 can be removed and other operations performed if desiredwith other instruments.

It should be appreciated that if desired, another embodiment of catheterapparatus used solely for imaging can be provided by mounting thecrystal at the end of the torque cable as illustrated in FIG. 8 so thatthe crystal is rotated about an axis parallel to the longitudinal axisof th housing.

From the foregoing, it can be seen that a two-dimensional ultrasoundimage is generated by rotating a crystal or a mirror that is located atthe tip of the catheter. Good resolution is obtained because of therelatively high frequency, i.e., 5 to 50 megahertz, that is used. Theimage that is created is generally perpendicular to the longitudinalaxis of the catheter, but may also be in a forward conical pattern,depending on the precise geometry of the transducer and/or mirror. Themotor or manual drive means that is utilized for rotating the transduceris external to the patient. Rotation, of the transducer is made possiblebecause of the electrical connection made with the brush contacts. Theuse of the balloon stabilizes the housing so that the cutting operationcan be readily accomplished.

The apparatus and system of the present invention makes it possible toobtain images in very small vessels and has made it possible toaccomplish the same by utilizing the precision driving of a veryflexible cable. The catheter apparatus in addition to being capable ofimaging is also capable of being steered by the flexible guidewiresecured to the tip.

It is apparent from the foregoing that there has been provided acatheter apparatus, system, and method which is particularly useful forintravascular two-dimensional ultrasonography and which can be utilizedwith many different types of operations, as for example, in performingatherectomies.

What is claimed is:
 1. A method of imaging and treating a region of ablood vessel using a catheter, said method comprising: advancing acatheter body having a distal region and an imaging device disposed atsaid distal region into the blood vessel until the imaging device islocated in a region to be treated, the imaging device having a rotatingreflector; generating an image of said region to be treated by rotatingthe imaging device within said catheter body and reflecting an imagingsignal off said rotating reflector of said imaging device; and inflatinga balloon disposed at said distal region of the catheter body such thatthe wall of the balloon contacts a partial or full occlusion in theblood vessel to apply a force to the occlusion to treat said region ofthe blood vessel.
 2. The method of claim 1 wherein said step ofgenerating an image includes providing said imaging device with anultrasound transducer.
 3. The method of claim 2 wherein said step ofgenerating an image includes generating a signal with said ultrasoundtransducer said signal having a frequency in the range from about 5 to50 megahertz.
 4. The method of claim 2 wherein said step of generatingan image includes generating a signal with said ultrasound transducer,said signal being directed generally axially relative to the bloodvessel and being deflected transversely by said rotating reflector. 5.The method of claim 4 wherein said step of generating an image includesgenerating a signal with said ultrasound transducer, said signal beingreflected off said rotating reflector.
 6. The method of claim 5 whereinsaid step of generating an image includes generating a backward image byreflecting said signal off said inclined rotating reflector.
 7. Themethod of claim 5 wherein said step of generating an image includesgenerating a forward image by reflecting said signal off said inclinedrotating reflector.
 8. The method of claim 5 wherein said rotatingreflector includes a mirrored surface.
 9. The method of claim 2 whereinsaid step of generating an image includes generating a signal with saidultrasound transducer, said signal being directed generally transverselyand said image being generated by rotating said rotating reflector ofsaid imaging device thereby generating a signal which is directed at thewall of the blood vessel.
 10. The method of claim 1 further comprisingthe step of re-canalizing the region of blood vessel usinginterventional means located in the distal region of said catheter body.11. The method of claim 10 wherein said step of re-canalizing includesproviding said interventional means with a rotating blade.
 12. Themethod of claim 10 wherein said step of re-canalizing includes providingsaid interventional means with an abrasive surface.
 13. The method ofclaim 10 wherein said step of re-canalizing includes providing saidinterventional means with a perfusion port for the delivery of drugs.14. A method of imaging and treating a region of a blood vessel using acatheter, said method comprising: advancing a catheter body having animaging device into the blood vessel until the imaging device is locatedin a region to be treated the imaging device having a rotatingreflector; generating an image of said region to be treated by rotatingthe imaging device within said catheter body and reflecting an imagingsignal off said rotating reflector of said imaging device; and inflatinga balloon disposed at the distal region of the catheter body such thatthe wall of the balloon contacts a partial or full occlusion in theblood vessel to apply a force to the occlusion to assist in performingangioplasty.
 15. The method of claim 14 wherein said step of generatingan image includes providing said imaging device with an ultrasoundtransducer.
 16. The method of claim 15 wherein said step of generatingan image includes generating a signal with said ultrasound transducer,said signal having a frequency in the range from about 5 to 50megahertz.
 17. The method of claim 15 wherein said step of generating animage includes generating a signal with said ultrasound transducer, saidsignal being directed generally axially relative to the blood vessel andbeing deflected transversely by said rotating reflector.
 18. The methodof claim 16 wherein said step of generating an image includes generatinga signal with said ultrasound transducer, said signal being reflectedoff said rotating reflector.
 19. The method of claim 18 wherein saidstep of generating an image includes generating a backward image byreflecting said signal off said inclined rotating reflector.
 20. Themethod of claim 18 wherein said rotating reflector includes a mirroredsurface.
 21. The method of claim 18 wherein said step of generating animage includes generating a forward image by reflecting said signal offsaid inclined rotating reflector.
 22. The method of claim 15 whereinsaid step of generating an image includes generating a signal with saidultrasound transducer, said signal being directed generally transverselyand said image being generated by rotating said rotating reflector ofsaid imaging device thereby generating a signal which is directed at thewall of the blood vessel.
 23. The method of claim 14 further comprisingthe step of re-canalizing the region of blood vessel usinginterventional means located in the distal region of said catheter body.24. The method of claim 23 wherein said step of re-canalizing includesproviding said interventional means with a rotating blade.
 25. Themethod of claim 23 wherein said step of re-canalizing includes providingsaid interventional means with an abrasive surface.
 26. The method ofclaim 23 wherein said step of re-canalizing includes providing saidinterventional means with a perfusion port for the delivery of drugs.